Navigation Links
U-M receives NIH, FDA grant to study adaptive clinical trial designs
Date:10/7/2010

ANN ARBOR, Mich.Clinical trials in which participants are randomly assigned to different treatments by design are the cornerstone of clinical research. When conducted correctly, it's widely accepted by the research community that the results are valid and can be trusted.

But researchers at the University of Michigan hope to improve the process for bringing therapies and medical devices to patients by investigating the impact of a class of innovative trial designs known as adaptive clinical trials which make adjustments to the trial using information accumulated as patients are enrolled in hopes of improving the efficiency of clinical trials as a whole.

"One of the hard and firm rules of randomized clinical trials, and for good reason, is you can't just go changing your trial to get the results you want," says William Barsan, M.D., chair and director of the U-M Department of Emergency Medicine. "But with adaptive clinical trials, you spend a lot of time up-front asking yourself, 'What if?' so that any changes made throughout the course of the study are all agreed upon at the beginning, written into the study design and only changed throughout the course of the study based on pre-specified rules."

Researchers cannot always predict at what point a specific drug or treatment will show therapeutic results during the course of the study, if at all. Once a standard trial is underway, trial characteristics such as inclusion criteria cannot be modified or changed even if a sufficient amount of data collected before the trials end-date demonstrates that such changes may be necessary.

For example, remaining patients who are randomized to the placebo group cannot benefit from the therapeutic effect of the treatment, and money will continue to be spent until the trial ends. Current trials often include periodic review of data to search for early benefit or early harm but changes are usually only triggered when an overwhelming effect is seen.

Adaptive clinical trials can more seamlessly make use of accumulating information using Bayesian statistics which allow data analysts to predict trial success based on early patient responses and other accumulating information.

"Adaptive design essentially allows the statisticians to continuously reanalyze the data over the entire study and we can end up changing how patients are assigned within the study if it really looks like it's working," says Barsan, who is also principal investigator of the clinical trials coordinating center of the Neurological Emergencies Treatment Trials Network. "We believe this is one way to avoid getting false negatives and it's better protection for patients which is really important."

The three-year project, "Accelerating Drug and Device Evaluation through Innovative Clinical Trial Design," is one of four recipients of a $9.4 million award by the National Institutes of Health-Food and Drug Administration Joint Leadership Council to spearhead collaborative activities to stimulate a new research in regulatory science.

The project is led by Barsan, Donald A. Berry, Ph.D., senior statistical scientist and founder of Berry Consultants, and Roger J. Lewis, M.D., Ph.D., co-chair of the Regulatory and Ethics Knowledge and Research Program and professor of emergency medicine at the University of California Los Angeles.

The objective of the grant is to "optimize the design of four large, neurological emergency trials at various stages of development," Barsan says. "We'll use modeling and mathematical simulation to really kick the tires on a number of potential adaptive designs with the hope of gaining efficiency in the ultimate trial design. Hopefully it will lead to considerable savings in the research process and allow us to more accurately and rapidly identify treatments which improve patient outcomes."


'/>"/>

Contact: Jessica Soulliere
jesssoul@umich.edu
734-764-2220
University of Michigan Health System
Source:Eurekalert

Related medicine news :

1. NACDD Receives Two-Year Grant From Merck & Co., Inc. to Improve Diabetes Education
2. Dr Yaghouti of Global Laser Vision Receives Patient's Choice Award for 2009
3. UT researcher receives $2.4 million to research obesity, high-risk pregnancy
4. BestMassage.com Receives Award for Customer Trust
5. Corporate Wellness Firm Limeade Receives SAS 70 Type II Report
6. Oridion Receives Frost & Sullivan's 2010 Customer Value Enhancement Award
7. Special Olympics Georgia Receives Grant from The Home Depot Foundation
8. NOVAVAX, Inc. Receives NASDAQ Non-Compliance Letter
9. WuXi PharmaTech Receives AAALAC Accreditation for Suzhou Toxicology Facility
10. Verdan Receives Patent on Crystal Deodorant Spray
11. Thomas E. Mower Meets With Dalai Lama; Receives Prestigious Champion Award from Whole Child International
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... ... February 11, 2016 , ... From March ... Academy of Dermatology Annual Meeting at the Walter E. Washington Convention Center in ... for both the condition of hyperhidrosis (excessive sweating) and its treatment options. Specifically, ...
(Date:2/11/2016)... ... February 11, 2016 , ... Husted Kicking has completed its Third ... February 6th & 7th, 2016 according to kicking coach Michael Husted. , “This event ... the NFL’s combine in Indianapolis,” says Husted. “The NFL uses a third party organization ...
(Date:2/11/2016)... ... February 11, 2016 , ... The book, “Computers Should ... services, what questions to ask your IT consultant before signing a contract and how ... computer network. , “With companies relying heavily on e-mail and technology, it’s more important ...
(Date:2/11/2016)... ... February 11, 2016 , ... As part of their 2015 end of ... Round Table Foundation (MDRTF), has gifted $10,000 to University of Chicago to support ovarian ... Billy Cundiff. , “We are honored to support a promising young investigator from Dr. ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... as the World Molecular Imaging Congress (WMIC), will be held in New York ... meeting is “Imaging Biology…Improving Therapy.” The congress will highlight and emphasize how imaging ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... F ast access to ... at the point of need   ... and services, has launched a ClinicalKey mobile app that enables ... Elsevier designed the mobile app to allow users to select access to ... Android and iOS formats for mobile phone and tablet. ...
(Date:2/11/2016)... , Feb. 11, 2016 Scientists ... cell-isolation method that opens the door to genetic ... now have been impossible to isolate with 100 ... isolate specific tumor types in various stages of ... variants of these cells that are clinically relevant, ...
(Date:2/11/2016)... , Feb. 11, 2016  NanoViricides, Inc. ... it has entered into an agreement with the ... nanoviricides® drug candidates in standard animal models of ... , Research Director. Dr. Romanowski has extensive experience ... --> Eric Romanowski , Research ...
Breaking Medicine Technology: